You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 3, 2024

PREPOPIK Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Prepopik, and when can generic versions of Prepopik launch?

Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Prepopik

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Try a Trial

Paragraph IV (Patent) Challenges for PREPOPIK
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREPOPIK Oral Solution citric acid; magnesium oxide; sodium picosulfate 10 mg, 3.5 g, and 12 g 202535 1 2014-05-21

US Patents and Regulatory Information for PREPOPIK

PREPOPIK is protected by two US patents.

Patents protecting PREPOPIK

Granular compositions of sodium picosulphate and potassium bicarbonate and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Granular compositions of magnesium oxide and citric acid and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PREPOPIK

When does loss-of-exclusivity occur for PREPOPIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08309287
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0818541
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 02152
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1406457
Estimated Expiration: ⤷  Try a Trial

Patent: 1820859
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0180215
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 07526
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 07526
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 38174
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4500
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 54873
Estimated Expiration: ⤷  Try a Trial

Patent: 11500549
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 06
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 07526
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10003588
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3899
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 07526
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 07526
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 73332
Estimated Expiration: ⤷  Try a Trial

Patent: 10112483
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 290670
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 07526
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1002131
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1330096
Estimated Expiration: ⤷  Try a Trial

Patent: 1381263
Estimated Expiration: ⤷  Try a Trial

Patent: 100072020
Estimated Expiration: ⤷  Try a Trial

Patent: 130105757
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 59716
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 18352
Estimated Expiration: ⤷  Try a Trial

Patent: 0924759
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 05953
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREPOPIK around the world.

Country Patent Number Title Estimated Expiration
Canada 2702152 PROCEDE DE FABRICATION D'UN PRODUIT PHARMACEUTIQUE (PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT) ⤷  Try a Trial
South Korea 20100072020 PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE ⤷  Try a Trial
Saudi Arabia 08290670 عملية تصنيع خاصة بمنتج صيدلاني من بيكوكبريتات الصوديوم (Manufacturing Process for a Pharmaceutical Sodium Picosulphate Product) ⤷  Try a Trial
Slovenia 2207526 ⤷  Try a Trial
Lithuania 2207526 ⤷  Try a Trial
Croatia P20180215 ⤷  Try a Trial
Denmark 2207526 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.